The CHMP has adopted a negative opinion for emapalumab in Europe for the treatment of primary HLH
Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announced that the Committee for Medicinal Products for Human use (CHMP) has adopted a negative opinion recommending a refusal of the marketing authorisation for emapalumab for the treatment of primary haemophagocytic lymphohistiocytosis (pHLH) in children under 18 years of age in Europe. The negative opinion was given after the re-examination requested by Sobi after the initial opinon in July 2020. “This recommendation by the CHMP is disappointing given the significant unmet medical need which exists for